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Betaseron (interferon beta-1b), also traded as Betaferon and soon Extavia, was originally developed by Schering AG (Berlex in North America), which is now part of Bayer HealthCare. Bayer currently markets Betaseron and Betaferon, and Novartis AG plans to introduce Extavia in 2009.
Interferon beta based drugs are used to treat secondary-progressive and relapse-remitting forms of multiple sclerosis (MS), and are approved for use after the first MS event. They have been shown to reduce the frequency of attacks and to slow the advance of MS.
Betaseron and other interferon-based drugs are believed to slow the progress of MS through their anti-inflammatory properties. They are also thought to improve the integrity of the blood-brain barrier (BBB), which prevents certain levels of undesirable substances from reaching the brain.
In April 2005, however, the US Food and Drug Administration (FDA) sent a letter to healthcare professionals as a reminder of the risk of hepatotoxicity associated with use of Betaseron. Since its approval in 1993, the prescribing information for Betaseron has recommended liver function testing at one, three, and six months after the initiation of therapy. It has also recommended periodic liver function testing thereafter, even in the absence of clinical symptoms.
Other potential side effects associated with the use of Betaseron include:
- Depression and suicide - Betaseron should be used with caution in patients with depression, and anyone using the drug should immediately report any symptoms of depression to their healthcare provider
- Injection site necrosis - has been reported in 4% of patients in controlled clinical trials. In rare extreme cases, debridement (removal of dead or contaminated tissue) and even skin grafting has been required
- Flu-like symptoms - in about 57 percent of patients in four clinical trials. The incidence diminishes over time
- Laboratory anomalies - such as neutropenia and increased SGPT, SGOT and hepatic enzymes
- Allergic reactions - including anaphylaxis, dyspnea, skin rash, urticaria, bronchospasm, and tongue edema
- Menstrual irregularities - mild to moderate cases in about 12 percent of patients in four clinical trials.
- Remote risk of viral disease transmitted by donors albumin (a derivative of blood)
Female patients should also be aware of the potential risk to pregnancy that Betaseron therapy poses.
If you or a loved one is suffering from side effects associated with Betaseron therapy, you may be entitled to compensation. For a thorough case evaluation, contact a qualified pharmaceutical injury attorney.